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NCT03580759 · ClinicalTrials.gov registry record · NA
Exergaming in Advanced HF With Multiple Chronic Conditions Prior to LVAD Implantation or Heart Transplant
A NA study, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT03580759: Completed NA study, sponsored by University of Nebraska.
NCT03580759 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03580759, a NA study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving either a left ventricular assist device (LVAD) or orthotopic heart transplantation (OHT). Prior to surgery, individuals with advanced HF/MCC experience a high symptom burden that often precludes them from participating in meaningful physical activity. Pre-surgical fitness programs have been used in other critically ill populations to improve function prior to surgery. Interactive gaming systems have been successfully used to engage other seriously ill adults in low-intensity physical activity. However, exergaming interventions have not yet been applied in individuals with advanced HF/MCC as prehabilitation prior to LVAD implantation or OHT. The investigators propose that a prehabilitation exergaming intervention will not only enhance pre-surgical outcomes but will also augment postoperative outcomes. This study is designed in two-phases. Phase 1 examines intervention feasibility and phase 2 is a pilot study with a two-group design. In phase 2, participants will be randomized to a usual care group or the exergaming intervention group. The exergaming group will participate in a low-intensity exergaming intervention and additional investigator-developed educational modules that will be delivered via the Nintendo Wii U exergaming system. The investigators will evaluate pre- and post-surgical frailty, fatigue, affective well-being, and immune function as primary outcomes. The investigators expect that participation in low intensity exergaming will improve these primary outcomes pre- and post-surgically, and decrease post-surgical complications and health care utilization. Investigator-developed modules will promote self-efficacy, self-regulation, and activation. This is the first s
Primary Outcome
Functional capacity will be assessed with a six-minute walk test. Subjects will be asked to walk for 6 min to determine what distance they can accomplish in that time period at a normal walking pace.
Interventions
- BEHAVIORAL PREHAB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2021-03-01 |
| Phase | NA |
What the finished NCT03580759 record still lists
NCT03580759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which PREHAB is the first listed.
NCT03580759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03580759 about?
NCT03580759 is a clinical study titled "Exergaming in Advanced HF With Multiple Chronic Conditions Prior to LVAD Implantation or Heart Transplant". The purpose of this study is to test a home-based exergaming intervention designed to decrease frailty and fatigue and improve affective well-being, functional capacity, and immune function in individuals with advanced heart failure (HF) and multiple chronic conditions (MCC) prior to receiving eithe...
What is the current status of trial NCT03580759?
This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2019-03-01. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT03580759?
The interventions under investigation include: PREHAB (BEHAVIORAL).
Who is sponsoring clinical trial NCT03580759?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03580759's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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